An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate the safety and tolerability of NNC0114-0006 in subjects with systemic lupus erythematosus (SLE) concomitantly treated with stable background therapies.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Investigation of NNC 0151-0000-0000 in Subjects With Systemic Lupus Erythematosus (SLE)

NCT01018238

Inflammation Systemic Lupus Erythematosus

WITHDRAWN PHASE1

An Investigation of AGS-009 in Patients With Systemic Lupus Erythematosus (SLE)

NCT00960362

Inflammation Systemic Lupus Erythematosus (SLE)

COMPLETED PHASE1

A Clinical Trial to Evaluate Safety of Gusacitinib in Patients With Systemic Lupus Erythematosus (SLE) or Lupus

NCT06238531

Systemic Lupus Erythematosus

WITHDRAWN PHASE1

Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus

NCT02554019

Systemic Lupus Erythematosus

COMPLETED PHASE2

BI 705564 in Patients With Systemic Lupus Erythematosus (SLE)

NCT03771885

Lupus Erythematosus, Systemic

WITHDRAWN PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammation Systemic Lupus Erythematosus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NNC0114-0006

Group Type EXPERIMENTAL

NNC0114-0006

Intervention Type DRUG

Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NNC0114-0006

Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.

Intervention Type DRUG

placebo

Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Men and women (not pregnant and not nursing)
* Subjects with SLE meeting the American College of Rheumatology (ACR) criteria, with a disease duration of at least 6 months
* Subjects with clinically active SLE defined as a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of at least 6 and positive for antinuclear antibody (ANA) and/or Anti-double-stranded DNA antibody (anti-dsDNA)
* If taken, background medication must be stable

Exclusion Criteria

* Presence or history of active lupus nephritis (LN) within the last 4 months or active central nervous system (CNS) disease within the last 12 months
* Body mass index (BMI) below 18 kg/m\^2 or above 38 kg/m\^2

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No